Treated and untreated cells will be stored 
separately in liquid nitrogen. They will be thawed 
and administered at the time of AuBMT in the 
standard fashion. 
5.4) Preparative regimen and bone marrow infusion : 
The autologous bone marrow transplantation will 
take place using current preparative regimens and 
infusion procedures (Appendix 2) . Both the treated 
and untreated bone marrow be infused. Standard 
supportive care measures will be used following 
bone marrow transplantation. In addition, patients 
will be monitored closely for adverse reactions to 
the inserted gene. 
5.5) Adverse Reaction Reporting Requirements : 
5.51) This protocol uses retroviral-mediated 
genetic material which is considered an 
IND agent. Toxicities occurring on this 
treatment should be considered IND 
related. 
5.52) The following adverse reactions must be 
reported to the NIH Office of Protection 
from Research Risks (OPRR) and the local 
IRB in the following manner described. 
In addition, a copy of the report will be 
forwarded to the NIH Office of 
Recombinant DNA Activities and the US 
Food and Drug Administration. 
5.521) Deaths 
Any death from any cause while 
a patient is receiving 
treatment on this protocol or 
up to 3 0 days after the last 
dose of protocol treatment, or 
any death which occurs more 
than 3 0 days after protocol 
treatment but which is felt to 
be treatment related, must be 
reported as follows: 
A telephone call must be made 
to the principal investigator 
Dr. Cornetta at 274-3589 and to 
the OPRR, Charles R. McCarthy, 
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Recombinant DNA Research, Volume 15 
